Vaginal applicator



United States Patent 3,262,450 VAGINAL APPLICATOR Nathaniel M. Elias, 56Washington Mews, New York, N.Y. No Drawing. Filed Apr. 2, 1962, Ser. No.184,538 4 Claims. (Cl. 128-270 This invention relates to improvements intopical applicators, more particularly to topical applicators to be usedon the mucous membranes of the vaginal cavity.

It is known to apply topical remedies and conception control media bymeans of sponges or sponge-like masses in the vaginal cavity. A methodfor the above-mentioned application is described in U.S. Patent No.2,943,979. This method has found considerable acceptance in conceptioncontrol practices; however, there has been still some reluctance inpotential users due to the bulkiness and appearance of the sponge-likemasses used heretofore.

The problem of overpopulation is increasingly gaining recognitionthroughout the world, especially in countries where such problems areeminently in the economic focus. One of the most serious problems inimpressing the population in such countries of the benefits, andnecessity of such practices, was the users reluctance towards suchpractices for esthetic reasons. Therefore, considerable ef forts havebeen made towards developing methods and means to facilitate thepractice of effective birth control methods and to devise more appealingones.

The most effective and economically most feasible methods involve theuse of foam producing spermicidal compositions which .are topicallyapplied with sponges or sponge-like masses. Marine sponges have beensuggested, but they are found unsatisfactory because of the large sizeof the pores and irregular cellular structure of the sponges and theirunavailability in a form having a uniform cellular structure and uniformapparent specific gravity. The apparent specific gravity of cellulosesponges is approximately 0.055 and that of rubber sponges isapproximately 0.l. The average pore size of these sponges is between 12mm. in diameter.

Because of the relatively large pores and the uneven cellular structureof known applicators the foam holding capacity and the amount of foamproduced, as compared to the size of the applicator was unsatisfactory,necessitating on occasion even repeated applications. The weight of theknown topical applicators is appreciably large, detracting from its aimin gaining popularity. The non-uniform and large pores contribute to thedecreased available area of pore sidewalls, also much was left to bedesired in strength and durability of the applicators.

It is an object of the invention, therefore, to provide topicalapplicators overcoming the disadvantages of prior applicators.

It is another object of the invention to provide an applicator -havingincreased user appeal and lighter weight.

It is yet another object of the invention to provide a topicalapplicator having increased strength and durability over knownapplicators.

Another object of the invention is to provide a topical applicatorhaving increased foaming agent-holding capacity and better continuousfoam exudation properties than known types of applicators.

It is a further function of the invention to provide topical applicatorshaving smoother and more even surfaces and improved shape.

According to the invention it has now been found that by usingsponge-like masses having an apparent specific gravity of between 0.01and 0.04 and a uniform cell structure, and in which the average poresize does not exceed 1.5 mm. diameter, the above-mentioned objects ofthe invention can be accomplished. By providing the appli- 3,262,450Patented July 26, 1966 ice cators according to the invention with asmaller and more uniform pore size, the surface of the walls of thecells is materially increased, therefore, the foaming agent-holdingcapacity of the applicator is greatly increased, furthermorecontributing to a more random distribution of the cellular buildingblocks of the mass giving it more strength, rigidity and durability.

As the foaming agent-holding capacity of the applicator is enlarged, anincreased capacity for the exudation of foam follows, whereby, it hasbeen found, the foam exudation takes place at an improved, more uniformrate and can be maintained throughout a materially longer period thanpossible theretofore.

Due to the larger average specific area (area per unit volume) of thesidewalls of the pores, the bulky appearance and the weight of theapplicator is decreased, in fact, it has been established in tests wherepatients were offered a choice between known topical applicators andtopical applicators according to the present invention, three times asmany patients chose the method providing for the use of the applicatoraccording to the invention.

Contributing to the user acceptance of the applicators is the fact thatthe cupping, shaping, or molding of the applicators results in a producthaving smoother and more uniformly even sidewalls and outlines due totheir uniform average pore size.

As mentioned briefly at the outset, the applicators according to thepresent invention are also useful in the treatment of various types ofvaginal disorders. Foaming materials, such as sodium lauryl sulfate orp-triisopropylphenoxypolyethoxy-ethanol are used in the treatment ofailments as such Trichomonas Vaginalis Vaginitis, in concentrated ordiluted aqueous solutions. The improved continuous exudation propertiesof the applicators of the present invention contribute to more effectivetreatment since the application of the medication thus can be madecontinuous for increasing periods without frequent and inconvenientrepeated applications.

For the purposes of applicators, according to the invention, preferablypolyester or polyether urethane foam sponge materials are used. Thepolyester urethane sponge materials generally belong to a class of foamsmade by reacting polyesters, which are formed by reacting dibasic acidssuch as succinic, sebacic, etc. acids, with difunctional alcohols, suchas, for example, propylene glycol with tolylene diisocyanate. Thepolyether urethane sponge materials generally belong to a class of foamsmade by reacting the polyoxypropylene adduct of a dior trihydroxyalcohol, such as, e.g., sorbitol, propylene glycol, or mixtures thereof,with tolylene diisocyanate, or the like.

In the following, several examples are to be given to better illustratethe invention. It should, however, be understood that many changes inthe details could be made without departing from the spirit of theinvention.

Example 1 According to this example of the invention, a spongy topicalapplicator is provided, made of a polyether urethane plastic material.The specific gravity of the applicator is 0.015 and the average poresize is 0.5 mm. The color of the sponge is shocking pink.

Example 2 The topical applicator in this example of the invention ismade of a pea-green polyester urethane plastic spongy material. Itsspecific gravity is 0.04 and its approximate average pore size is 1.5mm.

Example 3 Four sponges in the size of %"x2 /2"x2 /z were prepared, oneeach'from polyether urethane plastic, polyester urethane plastic,cellulose sponge and rubber sponge. The sponges used were of the finestpores available for size. 1

Each sponge was moistened with 4 cc. of water. Subsequently, A1. cc. ofa liquid, containing p-triisopropylphenoxypolyethoxyethanol and 8%sodium lauryl sulfate was applied to each side of each sponge and thenthe sponge in each case was gently compressed and expanded as often aspossible to develop the most foam that could be developed therefrom.

With the polyester and polyether sponges, each weighing 0.8 gram, avoluminous foam amounting to over 25 cc. was developed with gentlemanipulation and pressure. With the cellulose sponge, weighing 2 grams,less than 10 cc. of foam exuded to the surface even when considerablepressure and manipulation was applied. The rubber sponge weighed 4grams; about 7 cc. of foam were developed after considerablemanipulation and pressure. Less than half the pressure was required todeform the polyester or polyether urethane sponges and cause foam to bereleased than was required to deform the rubber or cellulose sponges tothe same degree.

The above disclosed embodiments and examples were not exclusiveembodiments and examples of the invention, therefore, the scope thereofis to be interpreted from the appended claims.

What I claim is:

1. A topical applicator for vaginal insertion, comprising a porousflexible and elastic body made of a polyurethane foam material, saidbody having a network distributed at random therein, the apparentspecific gravity of said body being between 0.01 and 0.04, and theaverage distance between opposing sidewalls not exceeding 1.5

mm., said applicator further including a foam producing material betweensaid sidewalls.

2. An applicator for vaginal insertion according to claim 1 wherein saidbody is made of a polyether urethane sponge material.

3. An applicator for vaginal insertion according to claim 1 wherein saidbody is made of a polyester urethane sponge material.

4. A process for applying a topical agent in the'vaginal cavity,comprising the steps of impregnating a cellular sponge of polyurethaneplastic with a foam producing agent, said cells in the sponge forming anetwork distributed at random and having sidewalls whose opposing facesare spaced from each other at a distance of up to 1.5 mm., producingfoam from said agent within said applicator, and placing the foam filledapplicator into a I vaginal cavity.

References Cited by the Examiner OTHER REFERENCES Stone et al., In HumanFertility, 10 (3) pp. -73, September 1945.

Hoppe, Kunstsofie, vol. 42, No. 12, December 1952,

Rogers, T. H., Elastomeric Cellular Materials II, in Rubber World,132(1)), pp. 753-757, September 1955.

RICHARD A. GAUDET, Primary Examiner.

FRANK CACCIAPAGLIA, ]R., Examiner. E. FRANK, C. F. ROSENBAUM, AssistantExaminers.

1. A TOPICAL APPLICATOR FOR VAGINAL INSERTION, COMPRISING A POROUSFLEXIBLE AND ELASTIC BODY MADE OF A POLYURETHANE FOAM MATERIAL, SAIDBODY HAVING A NETWORK DISTRIBUTED AT RANDOM THEREIN, THE APPARENTSPECIFIC GRAVITY OF SAID BODY BEING BETWEEN 0.01 AND 0.04, AND THEAVERAGE DISTANCE BETWEEN OPPOSING SIDEWALLS NOT EXCEEDING 1.5 MM., SAIDAPPLICATOR FURTHER INCLUDING A FOAM PRODUCING MATERIAL BETWEEN SAIDSIDEWALLS.